Federal Register / Vol. 70, No.
82 / Friday, April 29, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10117, 10118,
10119, 10135, 10136 and CMS–R–138]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Application for Coordinated
Care, Private Fee-for-Service, Regional
Preferred Provider Organization, Service
Area Expansion for Coordinated Care
and Private Fee-for-Service Plans,
Medical Savings Account Plans; Form
Nos.: CMS–10117, 10118, 10119, 10135,
10136 (OMB # 0938–0935); Use: Health
plans must meet certain regulatory
requirements to enter into a contract
with CMS to provide health benefits to
Medicare beneficiaries. These
applications are the collection forms to
obtain the information from a health
plan that will allow CMS staff to
determine compliance with the
regulations; Frequency: Other—one-time
submission; Affected Public: Business or
other for-profit, Not-for-profit
institutions, and State, Local or Tribal
Government; Number of Respondents:
420; Total Annual Responses: 520; Total
Annual Hours: 20,100.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Geographic Classification Review Board
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22317
(MGCRB) Procedures and Supporting
Regulations in 42 CFR Sections 412.256
and 412.230; Form Nos.: CMS–R–138
(OMB #0938–0573); Use: Section
1886(d)(10) of the Social Security Act
established the Medicare Geographic
Classification Review Board (MGCRB),
an entity with the authority to accept
short-term hospital inpatient
prospective payment system
applications from hospitals requesting
geographic reclassification for wage
index or standardized payment amounts
and to issue decisions on these requests.
This regulation sets up the application
process for prospective payment system
hospitals that choose to appeal their
geographic status to the MGCRB. This
regulation also establishes procedural
guidelines for the MGCRB; Frequency:
Reporting—Annually; Affected Public:
Business or other for-profit, Not-for-
profit institutions; Number of
Respondents: 500; Total Annual
Responses: 500; Total Annual Hours:
500.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at http://www.cms.hhs.gov/
regulations/pra/, or e-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
Written comments and
recommendations for the proposed
information collections must be mailed
within 60 days of this notice to the
address below:CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations
Development,Attention: Melissa
Musotto, PRA Specialist,Room C4–26–
05,7500 Security Boulevard,Baltimore,
Maryland 21244–1850.
Dated: April 22, 2005.
Michelle Shortt,
Acting Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 05–8713 Filed 4–28–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2207–N]
Medicare, Medicaid, and CLIA
Programs; Clinical Laboratory
Improvement Amendments of 1988;
Continuance of Exemption of
Laboratories Licensed by the State of
Washington
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice announces that
laboratories located in the State of
Washington that possess a valid license
under the Medical Test Site Licensure
Law, Chapter 70.42 of the Revised Code
of Washington (RCW), continue to be
exempt from the requirements of the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) until April
30, 2007.
DATES: The continuance granted by this
notice is effective until April 30, 2007.
FOR FURTHER INFORMATION CONTACT:
Sandra Farragut, (410) 786–3531.
SUPPLEMENTARY INFORMATION:
I. Background
Section 353 of the Public Health
Service Act (PHS Act), as amended by
the Clinical Laboratory Improvement
Amendments of 1988, Pub. L. 100–578
(CLIA), provides that no laboratory may
perform tests on human specimens
unless it has a certificate to perform
these tests issued by the Secretary of the
Department of Health and Human
Services (HHS). Under section 1861(s)
of the Social Security Act, the Medicare
program will pay for laboratory services
only if the laboratory has a CLIA
certificate. Section 1902(a)(9)(C) of the
Social Security Act requires that State
Medicaid plans pay only for laboratory
services furnished by CLIA-certified
laboratories. Thus, although subject to
specified exemptions, laboratories
generally must have a current and valid
CLIA certificate to test human
specimens and to be eligible for
payment from the Medicare or Medicaid
programs. Regulations implementing
section 353 of the PHS Act are
contained in 42 CFR part 493.
Section 353(p) of the PHS Act
provides for the exemption of
laboratories from CLIA requirements in
a State that applies requirements that
are equal to or more stringent than those
of CLIA.
Regulations in 42 CFR part 493
subpart E implement section 353(p) of
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